Some of the key issues the Agreement Workplan seeks to address includes:

Support sector stability and sustainability

Reduce the time to market for medical devices

Ensure Australian patients have access to safe, effective, and cost effective innovative medical devices in the private sector

Improve the transparency and efficiency of the Prostheses List arrangements

Recognise superior clinical performance

Support Australian medical technology innovation

“The release of the Agreement workplan and industry working groups terms of reference is important to ensure transparency around this process and the delivery of reforms that are in the Agreement,” said Ian Burgess, Chief Executive Officer of the Medical Technology Association of Australia.

“Under this Agreement, the MedTech industry is incurring revenue cuts of $1.1 billion which goes directly to the private health insurance companies to improve the affordability of their insurance products.

“We are the major reason that this year’s average private health insurance premium increase was the lowest in 17 years.

“Full implementation of the reforms contained in the Agreement is essential to ensure that patients benefit from improved access to medical technology.”

Under the Agreement, three Industry Working Groups (IWGs) have been established each with a specific focus.

The most challenging of the three includes developing a revised framework for benefit setting and benefit review reflecting the use of health technology assessment (HTA) including evaluation of the value, cost-effectiveness and innovation of medical technology.

The second involving reducing red tape to improve the transparency and efficiency of the Prostheses List (PL) arrangements through the quality and content of the information contained in the Guidelines and the Prostheses List Management System (PLMS).

Lastly, the Cardiac Technical Support Services has been tasked to make recommendations and provide advice on how technical support services for active implantable cardiac devices should be funded to ensure the Australian healthcare system and privately insured patients receive maximum benefit from this technology.

“For example, the removal of two-year follow-up clinical data as an unnecessary and standard requirement for assessment of some devices will greatly improve access to market.

“Sufficient clinical evidence, appropriate to the device, will still need to be submitted to enable a comparative assessment of clinical performance for the purposes of setting benefits on the PL.

“This will ensure the PL remains robust but recognises the quantum of follow-up data required will vary with the type of prosthesis, its intended use and the quantity of other relevant clinical evidence available or previously assessed.”

The Workplan makes it clear the Agreement will review ways to list new targeted devices on the PL that do not meet the current criteria for listing by 30 June 2020.

“Further, as reiterated by Hearts4Heart – Time to Change the Beat report non-implantable devices such as catheter ablation need to be included on the PL to relieve pressure on public waiting lists for patients with atrial fibrillation, said Mr Burgess.

“Inequity of treatment is not in the best interest of private health insurance policy holders.

“We believe access to a full range of medical technology is the most valuable component of a private health insurance policy and we’re committed to doing what we do best – assist patients lead healthier and more productive lives.”

1 Comment

This is all good however until those who are purchasing fully understand the need for significantly better scrutiny of medical device regulatory compliance the safety of patients will continue to be compromised. Checking if a product has an ARTG number does not necessarily establish whether or not a manufacturer or importer has indeed fulfilled the requirements of their Declaration of Conformity and are able to evidence a well documented product Technical File to support their claims.
The only way to “Ensure Australian patients have access to safe, effective, and cost effective innovative medical devices in the private sector” is to check the product claims before you place an order. This is the most mature, informed way to go about the product scrutiny process.

I am all in favour of efforts to “Reduce the time to market for medical devices” however not at the expense of patient safety and certainly not if good local manufacturers, who can evidence compliance, are forced to close down their businesses because of having to reduce their prices to compete with non compliant imports that cost a fraction of the price.

I caution any funding body to proceed with great caution. In a highly regulated industry business life can be very demanding so I hope those who have business integrity and can prove that their goods and services are indeed what they claim them to be are rewarded accordingly. That patients and protected and that their needs are satisfied through the process of procurement excellence. The Australian Healthcare market, with regard to medical device purchasing, is a long way from being in that place as it currently stands. Bring on simplicity but please do not go about it with haste.